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Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity.
J Neurol Neurosurg Psychiatry 1997; 63(2):204-9JN

Abstract

OBJECTIVES

To compare clinical effectiveness and health related quality of life in patients with severe spasticity who received intrathecal baclofen or a placebo.

METHODS

In a double blind, randomised, multicentre trial 22 patients were followed up during 13 weeks and subsequently included in a 52 week observational longitudinal study. Patients were those with chronic, disabling spasticity who did not respond to maximum doses of oral baclofen, dantrolene, and tizanidine. After implantation of a programmable pump patients were randomly assigned to placebo or baclofen infusion for 13 weeks. After 13 weeks all patients received baclofen. Clinical efficacy was assessed by the Ashworth scale, spasm score, and self reported pain, and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL).

RESULTS

At three months the scores of the placebo and baclofen group differed slightly for the spasm score (effect size=0.20) and substantially for the Ashworth scale (effect size=1.40) and pain score (effect size=0.94); health related quality of life showed no significant differences. Three months after implantation the baclofen group showed a significant, substantial improvement on the SIP "physical health", "mental health", "mobility", and "sleep and rest" subscales and on the HSCL mental health scale; patients receiving placebo showed no change. After one year of baclofen treatment significant (P<0.05) improvement was found on the SIP dimensions "mobility" and "body care and movement" with moderate effect sizes. Improvement on the SIP subscale "physical health" (P<0.05; effect size 0.86), the SIP overall score (without "ambulation"), and the "physical health" and overall scale of the HSCL was also significant, with effect sizes >0.80. Changes in health related behaviour were noted for "sleep and rest" and "recreation and pastimes" (P<0.01, P<0.05; effect size 0.95 and 0.63, respectively). Psychosocial behaviour showed no improvement.

CONCLUSIONS

Intrathecal baclofen delivered by an implanted, programmable pump resulted in improved self reported quality of life as assessed by the SIP, and HSCL physical health dimensions also suggest improvement.

Authors+Show Affiliations

Northern Centre for Health Care Research, Faculty of Medical Sciences, University of Groningen, the Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9285459

Citation

Middel, B, et al. "Effect of Intrathecal Baclofen Delivered By an Implanted Programmable Pump On Health Related Quality of Life in Patients With Severe Spasticity." Journal of Neurology, Neurosurgery, and Psychiatry, vol. 63, no. 2, 1997, pp. 204-9.
Middel B, Kuipers-Upmeijer H, Bouma J, et al. Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. J Neurol Neurosurg Psychiatry. 1997;63(2):204-9.
Middel, B., Kuipers-Upmeijer, H., Bouma, J., Staal, M., Oenema, D., Postma, T., ... Stewart, R. (1997). Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. Journal of Neurology, Neurosurgery, and Psychiatry, 63(2), pp. 204-9.
Middel B, et al. Effect of Intrathecal Baclofen Delivered By an Implanted Programmable Pump On Health Related Quality of Life in Patients With Severe Spasticity. J Neurol Neurosurg Psychiatry. 1997;63(2):204-9. PubMed PMID: 9285459.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. AU - Middel,B, AU - Kuipers-Upmeijer,H, AU - Bouma,J, AU - Staal,M, AU - Oenema,D, AU - Postma,T, AU - Terpstra,S, AU - Stewart,R, PY - 1997/8/1/pubmed PY - 1997/8/1/medline PY - 1997/8/1/entrez SP - 204 EP - 9 JF - Journal of neurology, neurosurgery, and psychiatry JO - J. Neurol. Neurosurg. Psychiatry VL - 63 IS - 2 N2 - OBJECTIVES: To compare clinical effectiveness and health related quality of life in patients with severe spasticity who received intrathecal baclofen or a placebo. METHODS: In a double blind, randomised, multicentre trial 22 patients were followed up during 13 weeks and subsequently included in a 52 week observational longitudinal study. Patients were those with chronic, disabling spasticity who did not respond to maximum doses of oral baclofen, dantrolene, and tizanidine. After implantation of a programmable pump patients were randomly assigned to placebo or baclofen infusion for 13 weeks. After 13 weeks all patients received baclofen. Clinical efficacy was assessed by the Ashworth scale, spasm score, and self reported pain, and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL). RESULTS: At three months the scores of the placebo and baclofen group differed slightly for the spasm score (effect size=0.20) and substantially for the Ashworth scale (effect size=1.40) and pain score (effect size=0.94); health related quality of life showed no significant differences. Three months after implantation the baclofen group showed a significant, substantial improvement on the SIP "physical health", "mental health", "mobility", and "sleep and rest" subscales and on the HSCL mental health scale; patients receiving placebo showed no change. After one year of baclofen treatment significant (P<0.05) improvement was found on the SIP dimensions "mobility" and "body care and movement" with moderate effect sizes. Improvement on the SIP subscale "physical health" (P<0.05; effect size 0.86), the SIP overall score (without "ambulation"), and the "physical health" and overall scale of the HSCL was also significant, with effect sizes >0.80. Changes in health related behaviour were noted for "sleep and rest" and "recreation and pastimes" (P<0.01, P<0.05; effect size 0.95 and 0.63, respectively). Psychosocial behaviour showed no improvement. CONCLUSIONS: Intrathecal baclofen delivered by an implanted, programmable pump resulted in improved self reported quality of life as assessed by the SIP, and HSCL physical health dimensions also suggest improvement. SN - 0022-3050 UR - https://www.unboundmedicine.com/medline/citation/9285459/Effect_of_intrathecal_baclofen_delivered_by_an_implanted_programmable_pump_on_health_related_quality_of_life_in_patients_with_severe_spasticity_ L2 - http://jnnp.bmj.com/cgi/pmidlookup?view=long&amp;pmid=9285459 DB - PRIME DP - Unbound Medicine ER -